The Clinical Challenge of Prosthetic Valve Endocarditis: JACC Focus Seminar 3/4.

During the past 6 decades, there have been numerous changes in prosthetic valve endocarditis (PVE), currently affecting an older population and increasing in incidence in patients with transcatheter-implanted valves. Significant microbiologic (molecular biology) and imaging diagnostic (fluorine-18 fluorodeoxyglucose-positron emission tomography/computed tomography) advances have been incorporated into the 2023 Duke-International Society for Cardiovascular Infectious Diseases infective endocarditis diagnostic criteria, thus increasing the diagnostic sensitivity for PVE without sacrificing specificity in validation studies. PVE is a life-threatening disease requiring management by multidisciplinary endocarditis teams in cardiac centers to improve outcomes. Novel surgical options are now available, and an increasing set of patients may avoid surgical intervention despite indication. Selected patients may complete parenteral or oral antimicrobial treatment at home. Finally, patients with prosthetic valves implanted surgically or by the transcatheter approach are candidates for antibiotic prophylaxis before invasive dental procedures.

Optimal oversizing in transcatheter aortic valve replacement with the self-expanding Evolut valve system.

OBJECTIVES: Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. METHODS: We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. RESULTS: The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). CONCLUSIONS: In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

Comparison of Mid-Term Prognosis in Intermediate-to-Low-Risk Contemporary Population with Guidelines-Oriented Age Cutoff.

BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.

Procedural success in transaxillary transcatheter aortic valve implantation according to type of transcatheter heart valve: results from the multicenter TAXI registry.

BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.

Infective Endocarditis After Transcatheter Versus Surgical Aortic Valve Replacement.

BACKGROUND: Scarce data are available comparing infective endocarditis (IE) following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study aimed to compare the clinical presentation, microbiological profile, management, and outcomes of IE after SAVR versus TAVR. METHODS: Data were collected from the "Infectious Endocarditis after TAVR International" (enrollment from 2005 to 2020) and the "International Collaboration on Endocarditis" (enrollment from 2000 to 2012) registries. Only patients with an IE affecting the aortic valve prosthesis were included. A 1:1 paired matching approach was used to compare patients with TAVR and SAVR. RESULTS: A total of 1688 patients were included. Of them, 602 (35.7%) had a surgical bioprosthesis (SB), 666 (39.5%) a mechanical prosthesis, 70 (4.2%) a homograft, and 350 (20.7%) a transcatheter heart valve. In the SAVR versus TAVR matched population, the rate of new moderate or severe aortic regurgitation was higher in the SB group (43.4% vs 13.5%; P < .001), and fewer vegetations were diagnosed in the SB group (62.5% vs 82%; P < .001). Patients with an SB had a higher rate of perivalvular extension (47.9% vs 27%; P < .001) and Staphylococcus aureus was less common in this group (13.4% vs 22%; P = .033). Despite a higher rate of surgery in patients with SB (44.4% vs 27.3%; P < .001), 1-year mortality was similar (SB: 46.5%; TAVR: 44.8%; log-rank P = .697). CONCLUSIONS: Clinical presentation, type of causative microorganism, and treatment differed between patients with an IE located on SB compared with TAVR. Despite these differences, both groups exhibited high and similar mortality at 1-year follow-up.

Long-term survival after cardiac arrest in patients undergoing emergent coronary angiography.

AIM: To determine long-term survival of patients after cardiac arrest undergoing emergent coronary angiography and therapeutic hypothermia. METHODS: We analysed data from patients treated within the regional STEMI Network from January 2015 to December 2020. The primary endpoint was all-cause mortality at median follow-up. Secondary endpoints were periprocedural complications (arrhythmias, pulmonary edema, cardiogenic shock, mechanical complication, stent thrombosis, reinfarction, bleeding) and 6-month all-cause death. A landmark analysis was performed, studying two time periods; 0-6 months and beyond 6 months. RESULTS: From a total of 24,125 patients in the regional STEMI network, 494 patients who suffered from cardiac arrest were included and divided into two groups: treated with (n = 119) and without therapeutic hypothermia (n = 375). At median follow-up (16.0 [0.2-33.3] months), there was no difference in the adjusted mortality rate between groups (51.3 % with hypothermia vs 48.0 % without hypothermia; HRadj1.08 95%CI [0.77-1.53]; p = 0.659). There was a higher frequency of bleeding in the hypothermia group (6.7 % vs 1.1 %; ORadj 7.99 95%CI [2.05-31.2]; p = 0.002), without difference for the rest of periprocedural complications. At 6-month follow-up, adjusted all-cause mortality rate was similar between groups (46.2 % with hypothermia vs 44.5 % without hypothermia; HRadj1.02 95%CI [0.71-1.47]; p = 0.900). Also, no differences were observed in the adjusted mortality rate between 6 months and median follow-up (9.4 % with hypothermia vs 6.3 % without hypothermia; HRadj2.02 95%CI [0.69-5.92]; p = 0.200). CONCLUSIONS: In a large cohort of patients with cardiac arrest within a regional STEMI network, those treated with therapeutic hypothermia did not improve long-term survival compared to those without hypothermia.

Incidence, predictors, and prognostic significance of impaired functional status early after transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. METHODS: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. RESULTS: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. CONCLUSIONS: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.

BACKGROUND: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. OBJECTIVES: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. METHODS: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. RESULTS: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. CONCLUSIONS: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. RESULTS: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Cardiac Death After Transcatheter Aortic Valve Replacement With Contemporary Devices.

BACKGROUND: The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown. OBJECTIVES: This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices. METHODS: This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves. RESULTS: After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR. CONCLUSIONS: Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD.

Non-Pharmacological Stroke Prevention in Atrial Fibrillation.

Atrial fibrillation (AF) is the most common arrhythmia worldwide. It is associated with increased mortality and morbidity, especially due to the increased risk of ischemic stroke and systemic embolism in these patients. For this reason, thromboembolism prevention is the cornerstone of managing AF, and oral anticoagulation is nowadays the first-line treatment. However, since most thrombi form in the left atrial appendage and anticoagulant therapy may have side effects and be contraindicated in some patients, surgical and percutaneous left atrial appendage occlusion (LAAO) have emerged as a non-pharmacological alternative. This review summarizes all existing evidence on surgical and percutaneous LAAO.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry.

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n = 1,160) whereas EVOLUT PRO was implanted in 21.7% (n = 321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p = 0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. METHODS: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). CONCLUSIONS: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry.

BACKGROUND: Myocardial revascularization failure (MRF) and Secondary revascularization (SR) are contemporary interventional cardiology challenges. AIM: To investigate the characteristics, management, and prognosis of patients with myocardial revascularization failure (MRF) and need for secondary revascularization (SR) in contemporary practice. METHODS: The REVASEC study is a prospective registry (NCT03349385), which recruited patients with prior revascularization referred for coronary angiography at 19 centers. The primary endpoint is a patient-oriented composite (POCE) at 1 year, including death, myocardial infarction, or repeat revascularization. RESULTS: A total of 869 patients previously revascularized by percutaneous intervention (83%) or surgery (17%) were recruited. MRF was found in 83.7% (41.1% stent/graft failure, 32.1% progression of coronary disease, and 10.5% residual disease). SR was performed in 70.1%, preferably by percutaneous intervention (95%). The POCE rate at 1 year was 14% in the overall cohort, with 6.4% all-cause death. In the multivariate analysis, lower POCE rates were found in the groups without MRF (9.4%) and with disease progression (11%) compared with graft/stent failure (17%) and residual disease (18%), hazard ratio 0.67 (95% confidence interval: 0.45-0.99), p = 0.043. At 1 year, the SR group had less chronic persistent angina (19% vs. 34%, p < 0.001), but a higher rate of repeat revascularization (9% vs. 2.9%, p < 0.001). CONCLUSION: MRF was found in 84% of patients with prior revascularization referred for coronary angiography. Stent/graft failure and residual coronary disease were associated with a worse prognosis. SR provided better symptom control at the expense of a higher rate of new revascularization.

Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry.

BACKGROUND: Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce. AIMS: This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure. METHODS: All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included. RESULTS: Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%). CONCLUSIONS: Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

Coronary Obstruction After Transcatheter Aortic Valve Replacement: Insights From the Spanish TAVI Registry.

BACKGROUND: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied. OBJECTIVES: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR. METHODS: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort. RESULTS: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001). CONCLUSIONS: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.